Journal of Clinical and Aesthetic Dermatology

Updates on Psoriasis & Cutaneou Oncology

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S9 P r o c e e D i n G s JCAD jOUrnAl Of ClInICAl And AEsthEtIC dErMAtOlOgy september 2017 • volume 10 • number 9 • supplement who could achieve at least a 75-percent reduction from baseline of the sPGa x Bsa, as well as the percentage of patients who scored 0 (clear) or 1 (almost clear) in sPGa response with at least a two-point reduction from baseline. a total of 221 patients were enrolled in the study. at 16 weeks, the mean percentage change of the sPGa x Bsa was 48.1 percent for the apremilast group versus 10.2 percent of the placebo patients. sPGa x Bsa that showed at least a 75-percent reduction over baseline was achieved by 35.1 percent of apremilast patients compared to 12.3 percent of placebo patients. about one-third of apremilast patients (30.4%) had a PGa score of 0 or 1 after 16 weeks, compared to 9.6 percent of placebo patients. adverse events occurred in 62.6 percent of apremilast and 47.9 percent of placebo patients, most of which were not serious or severe; three serious and three severe adverse events occurred in the apremilast group compared to one severe adverse event in the placebo group. the rate of study discontinuation owing to adverse events was 4.1 percent for placebo patients versus 3.4 percent for the apremilast group. the most frequently reported adverse edects were diarrhea (29.3% vs. 16.4% for apremilast vs. placebo, respectively), headache (20.4% vs. 11.0%), nausea (17.7% vs. 9.6%), upper respiratory tract infections (6.8% vs. 4.1%), decreased appetite (4.1% vs. 5.5%), and vomiting (6.1% vs. 2.7%). certolizumab pegol (cZP), ingiximab, adalimumab, golimumab, and etanercept are fve anti-tumor-necrosis-factor-alpha (anti- tnfa) drugs approved by the united states food and Drug administration (fDa) for treating psoriatic arthritis. at the late-breaking sessions of the 2017 american academy of Dermatology scientifc sessions, Gottlieb et al presented results of two randomized, double- blind, placebo-controlled, multicenter, 16- week, Phase 3 studies evaluating cZP in chronic plaque psoriasis patients: ciMPasi-1 (an eecacy and safety study of two Dose levels of certolizumab Pegol [cZP] in subjects With Plaque Psoriasis [Pso] nct02326298) and ciMPasi-2 (a study to evaluate the eecacy and safety of two Dose levels of certolizumab Pegol [cZP] in subjects With Plaque Psoriasis [Pso] nct02326272). 2 upon enrollment, patients were randomized in the 16-week, double-blind phase to placebo, cZP 200mg every two weeks (with a loading dose of cZP 400mg at Weeks 0, 2, and 4), or cZP 400mg every two weeks in a 1:2:2 ratio. the primary endpoints were the percentage of patients who, after 16 weeks of treatment, achieved a 75-percent reduction in their Pasi score (Pasi 75) and a PGa score of 0 (clear) or 1 (almost clear) on a 0-to-5 scale with at least a two- category improvement over baseline. at 16 weeks, patients moved into the maintenance phase (Weeks 16–48) and placebo patients were migrated to the lD-cZP group. nonresponders, defned as those with less than a Pasi 50 score, had the opportunity to withdraw at Weeks 32, 40, and 48 and progress to the next group or "escape" to 400mg cZP every two weeks. at 48 weeks, all patients remaining in the study were administered cZP 200mg every two weeks in an open-label treatment phase, which ran to 144 weeks. a safety follow-up phase continued to Week 152. there were signifcantly more responders in the cZP groups (both 200 and 400mg) versus placebo in terms of Pasi 75 and Pasi 90 rates, as well as PGa responder rates. the ciMPact study (eecacy and safety study of certolizumab Pegol [cZP] versus active comparator and Placebo in subjects With Plaque Psoriasis [Pso] nct02346240) evaluated placebo, 200mg cZP, 400mgcZP (every two weeks for both doses), and etanercept 50mg twice weekly (for 12 weeks) as an active comparator. Patients were randomized in a 1:3:3:3 scheme (1 for placebo) to enter an initial, 16-week, double-blind treatment phase. the primary endpoint was Pasi 75 at 12 weeks. after 16 weeks, patients entered the maintenance phase and from Week 48 to 144, followed by an open-label treatment phase. the cZP groups had signifcantly more Pasi 75 and Pasi 90 scores at Weeks 12 and 16 than placebo patients (table 1). 3 nEW And EMErgIng PsOrIAsIs trEAtMEnts from new studies on old drugs to innovative new agents, the systemic treatment of psoriasis remains in an exciting period of breakthroughs. Methotrexate. a new, randomized, double-blind, placebo-controlled, Phase 3 clinical trial from europe (MetoP [trial in Patients With Psoriasis treated With Methotrexate using an optimized treatment schedule nct02902861]) enrolled 149 methotrexate-naïve t AblE 1. ciMPact results at Weeks 12 and 16, Pasi 75 and Pasi 90 grOUP WEEK 12lPAsI 75 WEEK 16lPAsI 75 WEEK 16lPAsI 90 Placebo 5.0% 3.8% 0.3% etanercept 53.3% n/a n/a cZP-200mg 61.3%* 68.2%* 39.8%* cZP-400mg 66.7%* 74.7%* 49.1%* * result was statistically signifcantly superior to placebo (p<0.0001 for all) ciMPact: the eecacy and safety study of certolizumab Pegol (cZP) versus active comparator and Placebo in subjects With Plaque Psoriasis (Pso); Pasi: Psoriasis area and severity index; cZP: certolizumab

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